Pharmanovia — Sunosi EMA EPAR variation assessment report (EMEA/H/C/004893, 2020)
Pharmanovia · 2020 · EMA EPAR variation assessment report
Report summary
This report summarizes the assessment of pediatric study JZP865-101 for solriamfetol (Sunosi) in narcolepsy, fulfilling post-authorization commitments. The Phase 2a open-label trial investigated pharmacokinetics, safety, and preliminary efficacy in children and adolescents (6 to <18 years). Although the study demonstrated numerical improvements in sleepiness and a favorable safety profile, the small dataset prevents definitive efficacy conclusions. However, the findings support continued development of solriamfetol for this population.
Key findings — cited to the page
| Study initiation date | 25.11.2020 | JZP865-101 · p.5 |
| Study completion date | 04.02.2022 | JZP865-101 · p.5 |
| Final report date | 15.07.2022 | JZP865-101 · p.5 |
| Enrolment N | 12 participants | JZP865-101 · France, Belgium, Italy · p.5 |
| Enrolment N | 12 pediatric participants | JZP865-101 · p.6 |
| Age group 1 | 12 to < 18 years old | JZP865-101 · p.6 |
| Age group 2 | 6 to < 12 years old | JZP865-101 · p.6 |
| Participants with at least 1 TEAE (6 to < 12 years old) | 1 participant | JZP865-101 · p.11 |
| Total TEAEs reported | 6 TEAEs | JZP865-101 · p.11 |
| Participants with at least 1 TEAE | 5 participants | JZP865-101 · p.11 |
| Participants with at least 1 TEAE (12 to < 18 years old) | 4 participants | JZP865-101 · p.11 |
| CHMP adoption of conclusions | 10.11.2022 | · p.2 |
Source: Pharmanovia ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Psychiatry library →